Job Description Summary

Accountability is related to handling of Annual Product Quality Reviews (APQR). Annual Product Quality Review: Extract data from relevant sources tools/ applications. Interpret and compile external supplier APQR and/ or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review.

 

Job Description

Job Description:

Accountability is related to handling of Annual Product Quality Reviews (APQR). Annual Product Quality Review: Extract data from relevant sources tools/ applications. Interpret and compile external supplier APQR and/ or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review.

Your responsibilities include but are not limited to

• Collect contributory reports for product related evaluations. Interact with Suppliers and / or manufacturing sites as required.
• Support in updating and maintenance of APQR schedule as required. Compile and review of APQR report/ data as applicable to ensure it is complete and correct.
• Ensure completion of APQRs within defined timelines. Archival of the approved APQRs as applicable.  Communicate with external suppliers to provide applicable approved supplier APQR and related documents to QOP.
• Inform respective stakeholders/QAMs if there is any delay in receiving PQR and related documents from suppliers and External laboratories and take necessary actions. Support in volume distribution and tracking of APQRs till its approval.
• Update approved APQR data in e-compass file followed by interpretation of data to conclude product robustness.

Desirable Requirements:

• Bachelor’s or master’s degree in related technical discipline or equivalent experience demonstrated.
• Professional Experience: 1-3 years in Quality. Support the maintenance of the Country Quality Review (MAH/BRS) schedule. Coordinate with NCQ SPOCs and relevant manufacturing, packaging, testing, or batch releasing sites to facilitate drafting of the Country Quality Review forms.
• Extract and compile required data from relevant sources in line with the predefined format for Country Quality Reviews. Perform interpretation and consolidation of the compiled data.
• Review the compiled information for accuracy and completeness. Submit the finalized Country Quality Reviews to the respective Country Quality teams for approval.
• Ensure appropriate archival of approved Country Quality Review documents, as applicable.

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

 

Skills Desired

Collaboration, Communication, Data Integrity, Data Monitoring, Deadline Management, Good Manufacturing Practices (GMP), Health Safety Regulations, Process Control, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Inspections, Statistical Process Control (SPC)